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GSK to pay $3 billion to settle drug promotion charges.

GlaxoSmithKline has agreed to pay $3 billion to the federal government and plead guilty to charges of illegally promoting two antidepressants and withholding key safety information about the diabetes drug Avandia.

As part of the settlement, the pharmaceutical company is admitting to promoting the drugs Paxil and Wellbutrin for off-label uses and failing to report safety data about Avandia to the Food and Drug Administration.

In the case of Paxil, the government charges that, from 1998 to 2003, GSK sponsored dinner and spa programs to encourage physicians to prescribe the drug for children and adolescents, even though it was not approved for pediatric use. The government also alleges that the company prepared and published a misleading medical journal article providing false information about the efficacy of Paxil in patients under age 18. The government also charged that GSK paid physicians to promote off-label uses of Wellbutrin ranging from weight loss to the treatment of sexual dysfunction.

GSK also withheld safety data about the diabetes drug Avandia, including data from postmarketing studies and two other studies conducted in response to concerns about the cardiovascular side effects of the drug, according to the U.S. Department of Justice.

GSK will pay about $1 billion in penalties to the federal government for the illegal promotion of Avandia, Wellbutrin, and Paxil. GSK has agreed to pay another $2 billion in civil penalties to resolve allegations of fraud, including failure to give proper rebates to the Medicaid program.

The settlement is the largest health care fraud settlement in U.S. history and the $3 billion penalty will be the largest ever paid by a drug company, according to the U.S. Department of Justice.

Government officials said they want the settlement to serve as a warning to other drug manufacturers and companies that might seek to defraud the government.

In addition, GSK has entered into a 5-year Corporate Integrity Agreement with the Department of Health and Human Services. Among the provisions, GSK is required to change its pay structure to remove compensation based on sales goals for territories. The company also will require company executives to forfeit bonuses if they or their employees engage in significant misconduct. The settlement must be accepted by the U.S. District Court before it is finalized.
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Author:Schneider, Mary Ellen
Publication:Clinical Psychiatry News
Date:Aug 1, 2012
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